Prevention of postoperative bleeding in bone tumors surgery: A multicenter, randomized, parallel controlled clinical trial evaluating the efficacy of topic fibrin glue, topic tranexamic acid and normal haemostasia in patients undergoing massive bone resection.

• Conditions: Patients with bone tumor undergoing massive resection.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2011-006276-40-ES
• Lead Sponsor: Institut de Recerca Hospital Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Patients over 18 years
2) Bone tumor (primary or metastatic, benign or malignant) alocated in the extremities, or the pelvic or shoulder girdles.
3) Massive or block resection of bone tumor.
4) Signature of the patient's informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1) Allergy to tranexamic acid or fibrin glue
2) Background compatible with thromboembolic disease:
? Stroke
? Ischemic heart disease
? Deep vein thrombosis and / or superficial
? Pulmonary thromboembolism
? Peripheral arterial vascular disease
? Iron therapy in post-operative period
? Use of recuperatorsof blood during surgery
? Patients with thrombogenic arrhythmias
? Patients with prosthetic heart
? Coagulation disorders prothrombotic
? Treatment with contraceptive drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified